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    PROCEDURES

    EDUCATION & TRAINING

    CLINICAL DATA

    REIMBURSEMENT

    PHYSICIAN RESOURCES

    VIDEOS

    PATIENT RESOURCES

    PROCEDURES – TIF & cTIF

    TIF 2.0 procedure snapshots

    TIF 2.0® Procedure Overview

    The TIF 2.0® (Transoral Incisionless Fundoplication) procedure is an advanced endoscopic treatment that reconstructs the gastroesophageal flap valve (GEFV)—targeting the root anatomical cause of GERD (Gastroesophageal Reflux Disease). By restoring the natural antireflux barrier, TIF 2.0 offers a physiological solution without the need for external incisions or dissection.

    Using the EsophyX Z+® device, the procedure creates an approximately 3 cm, 270° esophagogastric fundoplication. This device employs proprietary tissue manipulation technology to place 20+ SerosaFuse® fasteners, distributing tension evenly across the wrap’s entire circumference under direct endoscopic visualization via a flexible endoscope positioned in the central lumen.

    The result is a reproducible, standardized, omega-shaped GEFV that closely mimics the patient’s natural anatomy, even in patients with hiatal hernias.

    TIF 2.0 procedure in video
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    PRODUCT ANIMATION VIDEO

    TIF 2.0 percentages

    Consecutive TIF: cTIF® Procedure

    For patients with hiatal hernias >2 cm, the TIF 2.0 procedure can be performed consecutively with a hiatal hernia repair during the same anesthesia session. This combined approach is known as cTIF®. Performing both procedures together allows for restoration of the antireflux barrier and diaphragmatic integrity.

    SerosaFuse® Fasteners: Strength You Can Trust

    • Made of non-resorbable polypropylene, SerosaFuse fasteners offer the tensile strength of a 3-0 suture.
    • Biocompatible and durable, they minimize local inflammation while supporting natural tissue healing.
    • Even placement aids in consistent wrap formation and long-term performance.

    Why TIF 2.0?

    GERD is a chronic and progressive disease, and proton pump inhibitors (PPIs) may not be suitable for all patients. TIF 2.0 provides a minimally invasive, anatomy-preserving alternative to traditional fundoplication techniques like Nissen. By reconstructing the GEFV and creating a 3 cm, 270° fundoplication, TIF 2.0:

    • Lengthens, strengthens, and tightens the lower esophageal sphincter (LES)
    • Restores natural antireflux function
    • Delivers reliable, reproducible results with minimal side effects2

    Conclusion

    The TIF 2.0 procedure, especially when combined with hiatal hernia repair as cTIF, represents a modern, endoscopic solution for GERD that prioritizes anatomical restoration and patient safety. With proven technology, standardized technique, and consistent outcomes, TIF 2.0 sets a new standard in minimally invasive reflux management.

    TIF 2.0 Education and Training

    EDUCATION & TRAINING

    Merit Medical is committed to supporting the development and implementation of your GERD program. We provide comprehensive training opportunities that include resources to help prepare both physician and staff. Per FDA requirement, if a physician has not done a case in a year, they must be retrained.

     

    Clinical Training Opportunities:

    The training is designed to promote the safe and effective use of the EsophyX Z+ device during the TIF 2.0 procedure. The training can be customized to individual and institutional requirements.

     

     

    Trainings are on a regular monthly cadence – please reach out to your Account Executive to register for the next training date.

    Contact Us Today

    TIF 2.0 Module 1Module 1: Peer-to-peer Didactic Lecture:

    A lecture by a Merit Medical Faculty member covering GERD anatomy, patient selection, the EsophyX Z+ device, and the TIF 2.0 and cTIF procedures.

     

    TIF 2.0 Module 2Module 2: EsophyX Z+ Device and Procedure Overview:

    A didactic lecture (virtual or live) by a qualified Merit Medical individual, reviewing the EsophyX Z+ device and TIF 2.0 procedure, with an emphasis on device operation and instructions for use.

     

    TIF 2.0 Module 3Module 3: Hands-on Practice:

    Simulation on a training model, including device preparation, insertion, tissue manipulation, fastener placement, and removal.

     

    TIF 2.0 Module 4Module 4: Procedure Observation:

    Discussion of patient positioning, room setup, device preparation, procedure steps, diagnosis of hiatal hernia, and pre- and post-op EGD. This can be in-person or virtual.

     

    TIF 2.0 Module 5Curriculum Completion:

    Upon meeting the required training components, the attending physician can receive a certificate of completion. Merit Medical personnel also provide device in-service training for hospital staff.

     

    TIF 2.0 Module 6Post-Training Support:

    After training, a qualified Merit Medical individual will support up to 20 live cases (live or virtual) or until procedural autonomy is achieved.

    Learn More

    CLINICAL DATA

    The TIF 2.0 procedure is backed by robust clinical evidence and has been studied extensively.

    ASGE Guidelines for GERD

    The American Society for Gastrointestinal Endoscopy (ASGE) practice guidelines for GERD include TIF 2.0 and recommends evaluation for combined hiatal hernia repair and TIF (cTIF) in patients with confirmed GERD and a large hiatal hernia (>2 cm) and Hill grade III or IV.3 

     

    ASGE Guidelines for GERD

    TEMPO Trial

    Key research includes the TEMPO Trial, which showed the long-term durability of the procedure, and a prospective multicenter cohort study that evaluated its outcomes in both academic and community practices.4

     

     

    TEMPO Trial

     

    AFS Whitepaper on TIF 2.0

    Check out the whitepaper from the American Foregut Society summarizing published outcome data for the TIF 2.0 and cTIF procedures. The whitepaper outlines best practices including patient assessment and selection.5

    AFS Whitepaper on TIF 2.0

    Additional Research

    REIMBURSEMENT

    Navigating reimbursement for medical procedures can be complex. Merit Medical is committed to providing support to ensure a smooth process for your practice by offering a dedicated Reimbursement Guide and access to our TAP (Technical & Administrative Support) program. The TAP program provides expert assistance with coding, billing, and coverage inquiries for the TIF 2.0 procedure, helping you maximize efficiency and minimize administrative burden.

    Learn more about EsophyX Z+ coding for the TIF and cTIF procedures by downloading the Reimbursement Guide.

    For information about our professional patient access services, call 833-274-5070 or email us at [email protected].

    EsophyX Z+ Reimbursement Guide

    EsophyX Z+ Reimbursement Guide

    Download

    PHYSICAN RESOURCES

    Merit Medical offers a variety of resources to support medical professionals in both the clinic and the operating room.

    cTIF Physician Brochure

    cTIF Physician Brochure

    Download

    TIF Physician Brochure

    TIF Physician Brochure

    Download

    EsophyX Z+ Sales Sheet

    EsophyX Z+ Sales Sheet

    Download

    EsophyX Z+ Device

    view of the EsophyX Z Device handle

    Learn More

    Current IFUs

     

    EsophyX® Z+ Fastener Delivery Device – IFU (US English)

    SerosaFuse® Implantable Fasteners – IFU (US English)

     

    Learn More

    VIDEOS

    Biodigital TIF Animation Video
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    Biodigital TIF Animation Video

    Biodigital HHR Animation Video
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    Biodigital HHR Animation Video

    cTIF Procedure Video from Brewer/Parker
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    cTIF Procedure Video from Brewer/Parker

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    TIF Talk Dr. Juakiem and Becca Part 1

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    TIF Talk Dr. Juakiem and Becca Part 2

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    TIF Talk – Dr. Nguyen, Dr. Blevins, and Barbara

    Laparoscopic View of cTIF
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    Laparoscopic View of cTIF

    Assessing the GEJ and Evaluating the Hiatus
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    Assessing the GEJ and Evaluating the Hiatus

    TIF Animation + HHR
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    TIF Animation + HHR

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    EsophyX Z+ Infomercial

    Hear from Your Peers On Frequently Asked Questions

    Can you describe the diagnostic workup for a patient prior to determining if they are a candidate for TIF 2.0 or cTIF?

    What are the key advantages of TIF 2.0 or cTIF compared to other anti-reflux procedures?

    Are there any other medications you ask a patient to stop?

    What antibiotics do you administer to a patient undergoing a TIF 2.0 procedure?

    Do patients spend the night in the hospital after their procedure?

    Do you recommend stopping anti-coagulants? If you do, when should a patient recommence them?

    How long do you continue PPIs post procedure?

    What follow-up care and diet do you recommend post TIF 2.0 and cTIF?

    We often get asked from surgeons “Why would I do a TIF procedure if a patient needs a hiatal hernia repair, I can continue with a surgical procedure, which would avoid switching to an endoscopic procedure”. Can you comment on that?

    How does the TIF 2.0 or cTIF add value to your practice and the hospital?

    What is the durability of cTIF or TIF 2.0?

    Are there pros and cons of mesh vs no mesh in a hiatal hernia repair for cTIF?

    Can you describe the most relevant clinical data for TIF/cTIF?

    PATIENT RESOURCES

    Empowering patients with knowledge is crucial for successful treatment outcomes. Our Patient Resources section provides materials to help you educate patients about GERD and the TIF 2.0 procedure.

    cTIF Patient Brochure

    cTIF Patient Brochure

    Download

    Pre/Post Patient Instructions

    Pre/Post Patient Instructions Download

    Patient Access Program

    Patient Access Program Download

    TIF Poster

    TIF Poster

    Download

    TIF Tabletop Banner

    TIF Tabletop Banner

    Download

    GERD HRQL

    GERD HRQL

    Download

    Explore GERDHelp.com

    GERDHelp website

    Visit Website

    Patient Testimonials

    Patient Testimonials - TIF Talks

    Watch TIF Talks

    AFS GERD Spectrum Poster

    AFS GERD Spectrum Poster

    Download

     

    To order any of these patient resources, contact your local Merit Medical representative.

     

    Contact Us Today

     

     

    REFERENCES

    1. Merit Medical, data on file.
    2. Janu P, Shughoury AB, Venkat K, Hurwich D, Galouzis T, Siatras J, Streeter D, Korman K, Mavrelis G, Mavrelis P. Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Z+ Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. Surg Innov. 2019 Dec;26(6):675-686. doi: 10.1177/1553350619869449. Epub 2019 Aug 20. PMID: 31431138; PMCID: PMC6843624. https://pubmed.ncbi.nlm.nih.gov/31431138/
    3. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: summary and recommendations Desai, Madhav et al. Gastrointestinal Endoscopy, Volume 101, Issue 2, 267 – 284. https://www.giejournal.org/article/S0016-5107(24)03559-4/fulltext
    4. Trad KS, Barnes WE, Prevou ER, Simoni G, Steffen JA, Shughoury AB, Raza M, Heise JA, Fox MA, Mavrelis PG. The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective. Surg Innov. 2018 Apr;25(2):149-157. doi: 10.1177/1553350618755214. Epub 2018 Feb 6. PMID: 29405886; PMCID: PMC5946656. https://pubmed.ncbi.nlm.nih.gov/29405886/
    5. Brewer Gutierrez OI, Choi D, et al. American Foregut Society White Paper on Transoral Incisionless Fundoplication. Foregut: The Journal of the American Foregut Society. 2023;3(3):242-254. doi:10.1177/26345161231170788 https://journals.sagepub.com/doi/abs/10.1177/26345161231170788

    *Merit Medical defines the term “cTIF” as a consecutive Transoral Incisionless Fundoplication which consists of a Hiatal Hernia Repair (HHR) followed by a Transoral Incisionless Fundoplication (TIF) procedure under a single anesthesia setting.

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